Non-invasive Urine Output Management Clinical Trial
Official title:
Evaluating the Efficacy and Comfort of the PureWick Male External Catheter Against a Comparator in Healthy Volunteers
A Prospective, Randomized, Crossover, Single-blind, Single Center Healthy Volunteer Study conducted over 1 day, with 2 voids using the PW Male external catheter vs. comparator Sage PrimoFit™. This study is designed to assess the performance, comfort, and ease of use of the PW Male external catheter as compared to the comparator product.
In this prospective, post-market, crossover, single-blind, single center healthy volunteer study, healthy males will be randomized 1:1 to a treatment sequence using two devices (PureWick™ Male External Catheter and Sage PrimoFit™) and followed for 1 day through 2 voids. Approximately 50 participants will be enrolled in this study to obtain 44 evaluable subjects. This study is designed to assess the performance, comfort, and ease of use of the PW Male external catheter. The purpose of this study is to provide clinical evidence to compare the effectiveness and comfort of PureWick™ Male against a comparator for non-invasive urine output management in patients with varying male anatomy. Specifically, the study will collect data about how the male external catheters perform when participants are positioned on their side using a turning wedge with the head of the bed elevated, mimicking common patient positioning in the hospital setting. ;